Siemens Atellica IM aTG Test Kits Recalled for Positive Bias
Siemens Healthcare Diagnostics is recalling 114 Atellica IM aTG test kits because they show positive bias compared to WHO standards.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, significant injuries, or illnesses. The hazard is a technical bias in test results rather than a direct physical injury risk, fitting the Moderate category for low-risk contamination or labeling/standardization issues without reported harm.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 114 units of the Atellica IM aTG (500 test kit), Siemens Material Number 10995462. The recall covers specific kit lots ending in 317 or lower, including lot 56683313 (exp. 5/27/2019) and lot 70390317 (exp. 6/29/2019). The affected products were distributed nationwide and in numerous foreign locations.
The recall is due to positive bias in anti-thyroglobulin results when compared to the standardization to World Health Organization (WHO) Reference Preparation MRC 65/93 stated in the Instructions for Use. This issue affects both the Atellica IM aTG kit lots ending in 317 and lower and the ADVIA Centaur aTG kit lots ending in 316 and lower.
Healthcare facilities and laboratories that have received these specific kits should stop using them and contact Siemens Healthcare Diagnostics for instructions on return or replacement. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 114
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Siemens Healthcare Diagnostics, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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